TRIGEN 71640532Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556339046), received between Aug 29, 2024 and Aug 29, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K092748, K243364); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INTERNAL FIXATION SURGERY PERFORMED ON (B)(6)2019, THE PATIENT WAS PLAYING HOCKEY WHEN HE WAS HIT BY ANOTHER PLAYER AND SUSTAINED A PERIPROSTHETIC FRACTURE OF HIS RIGHT DISTAL FEMUR. TO ADDRESS THIS EVENT ADVERSE THE PATIENT UNDERWENT REMOVAL OF THE RETAINED HARDWARE AND OPEN REDUCTION INTERNAL FIXATION UTILIZING AN INTRAMEDULLARY NAIL ON (B)(6)2024. AFTER THE PROCEDURE, THE PATIENT WAS TAKEN TO THE PACU IN SATISFACTORY CONDITIONS.

  Patient problems: Bone Fracture(s)

  MAUDE report 20102944 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092748, K243364. One submission often covers many models, so check the product and lot details in each record.

• Z-1806-2025 · Mar 18, 2025 · Open, Classified
  META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690